Tamper resistant one-time use wristband and clasp and algorithm to enhance the practical use of radio frequency for proximity between two or more entities

ABSTRACT

An electronic patient monitoring system and method of operation that includes one or more generally non-metal, tamper-resistant patient identification and monitoring devices, an observer transmitter/receiver device configured to receive and detect one or more beacon signals that exceed a predetermined threshold from at least one of the not easily removable patient identification and monitoring devices, set a time to hold open a window for a response on the transmitter/receiver device, and send a request for information to the observer with the transmitter/receiver device, and a central computer system. Each of the transmitter/receiver device and the central computer system, including, at least, a computer processor, communications components and system software to communicate with the observer transmitter/receiver device at specified/predetermined time intervals to receive observer- and patient-specific information.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/344,506, filed Apr. 24, 2019, titled “TAMPER RESISTANT ONE-TIME USEWRISTBAND AND CLASP AND ALGORITHM TO ENHANCE THE PRACTICAL USE OF RADIOFREQUENCY FOR PROXIMITY BETWEEN TWO OR MORE ENTITIES,” now U.S. Pat. No.10,896,590, which is a national phase application under 35 USC 371 ofInternational Patent No. PCT/US2017/051545, filed Sep. 14, 2017, titled“TAMPER RESISTANT CLASP AND WRISTBAND APPARATUS AND ASSOCIATED PATIENTMONITORING SYSTEM AND METHOD OF USE,” now International Publication No.WO2018/053116, which claims the benefit of U.S. Provisional PatentApplication No. 62/394,637, filed Sep. 14, 2016, and titled “TAMPERRESISTANT ONE-TIME USE WRISTBAND AND CLASP AND ALGORITHM TO ENHANCE THEPRACTICAL USE OF RADIO FREQUENCY FOR PROXIMITY BETWEEN TWO OR MOREENTITIES.”

TECHNICAL AREA

The disclosed subject matter is in the field of patient monitoringsystems to ensure patient safety. The disclosed subject matter moreparticularly relates to a tamper resistant clasp and wristband with anassociated beacon and patient monitoring systems and improved methods ofsignal recognition and processing. In general, the systems have one ormore assigned facility staff members that actively monitor, i.e.,directly observe, patients under their care that are wearing the tamperresistant clasp and wristband at specific time intervals to ensure thepatients are engaging in safe behaviors and participating in thetherapeutic milieu.

BACKGROUND

Individuals are often in need of secure placement in a healthcarefacility to ensure that their safety and the safety of others within thecommunity will be maintained. When an individual is unable to care forhim/herself due to physical or mental disability or, for example, theindividual is unable to commit to maintain his/her own safety, or hasmade an attempt to end his/her life, inpatient psychiatric care issuggested. Although the description below relates to psychiatric care,the system and method are equally applicable to patients withoutpsychiatric issues, but with physical issues.

Inpatient psychiatric care is appropriate for individuals who arevoicing suicidal ideation and have expressed a specific and feasibleplan as to how they may successfully complete a suicide attempt.Likewise, inpatient care is appropriate for individuals who haverecently attempted suicide or made a serious suicidal gesture. Inpatientcare is the appropriate course of treatment for individuals who arevoicing homicidal ideation, precipitated by a diagnosed psychiatriccondition or as specified by an outpatient physician according tohis/her diagnosis and treatment strategy. Inpatient psychiatric care mayalso be appropriate for individuals who are unable to refrain fromself-harm such as excessive cutting behaviors or self-mutilation.Inpatient psychiatric care is appropriate for individuals who are unableto care for themselves due to a diagnosed psychiatric disorder whichinterferes with their ability to function effectively.

Inpatient psychiatric care typically consists of a free standing orhospital affiliated facility that is dedicated to the treatment of aprimary psychiatric disorder. Inpatient psychiatric facilities consistof locked, secured units which may serve a general adult population orbe specialized to a specific patient demographic such as adolescent,older adult, or patients with a dual diagnosis which would include apsychiatric diagnosis concurrent with a substance abuse issue.

Inpatient units are locked facilities and patients do not have freeaccess to enter or leave the unit and do not have access to somerestricted areas on the unit. The inpatient unit environment is asecured setting where careful consideration has been taken to ensuremost potentially hazardous environmental objects have been removed.Obvious objects of risk have been removed to lessen the potential forpatients harming themselves. Upon entering an inpatient facility allpatient belongings are examined for items that could be potentiallyharmful. Any sharp or potentially harmful items are confiscated andplaced in a secure area for use with direct staff supervision.

The physical environment of the unit has been adapted to ensure maximumsafety for the patients and staff. Shower rods and shower heads do notbear weight, light fixtures are recessed, cameras monitor common areasthroughout the unit.

Despite these adaptations, certain risk factors are inherent in theconfiguration of any inpatient psychiatric unit, and it would beimpossible and inhumane to remove any and all potentially harmful items.

Given this inherent risk and the need to ensure patient safety,inpatient psychiatric units closely observe all patients at specifiedtime intervals. The specified observation period is determined byqualified mental health professionals and may be modified dependent onthe risk factors that the patient is exhibiting. The highest level ofobservation would be a 1:1 observation status with a staff personassigned to monitor the patient's activities. The staff person typicallyneeds to be within arm's length of the patient and is not permitted tobe assigned any other unit responsibilities. The next level ofobservation is an eyesight status, wherein the staff member needs tomaintain visual contact at all times to monitor all of a patient'sactivities.

As used herein, “Visual Observation” is defined as the observation madeby an observer visually to determine the activity of the patient; and“Line-of-Sight” is defined as an electronic connection from the observerto the patient which, generally, is effectively made without obstaclesin the path of the signal.

Excluding these higher levels of continuous observation, all otherobservation checks relate to specified time intervals. The attendingphysician, or other qualified mental health professional, predetermineswhat specified time period would best suit the patient's needs forsafety. This specified time interval is shared with the unit staffmember(s) that are responsible for monitoring the patients. Thespecified time interval for the observation check to ensure patientsafety may be visually observed every 15 minutes, 30 minutes, 1 hour,etc. depending on the clinical needs of the specific patient.

When completing an observation check for a patient, a staff member isrequired to make rounds on the unit to ensure that the patients assignedto their care are engaged in safe behaviors. The staff member isrequired to personally witness, through a visual observation what eachpatient is doing (e.g., attending group therapy, sleeping, etc.), anddocument that this observation check was completed.

Currently, these observation checks are manually documented by unitstaff member(s), who document this information on a clipboard that holdsthe paper observation checklist. This observation checklist specifieswhere the patient is on the unit, and includes the initials of the staffmember that verified the patient(s) was/were visually observed forengagement in safe behavior at the specified time interval.

The current system presents many opportunities for human error, whichwelcomes risk for patient safety. With the current system, the unitobservation clipboard may have numerous (for example 15, 25 or more)separate observation documents. There may be numerous differentobservers assigned to a psychiatric unit at one time, depending on thesize of the unit as well as the observer to patient ratios specified bythe facility. It is very challenging for staff to accurately ensure thateach patient has been appropriately monitored without repeatedlyassessing all of these paper documents.

With the current system, it is possible to incorrectly identifypatients. A staff member may observe patients who are attending a grouptherapy session. By glancing in the group therapy room, a staff personmay make the assumption that all of the patients on the unit are inattendance, when in fact one or more patients may have excusedthemselves from the group and may be engaged in unsafe behaviors.

In addition, staff may be unsure of each patient's name on a unit. On aunit with numerous patients it is difficult for a staff person coming onduty to verify each individual's name, and match it to the specificobservation checklist specific to that patient on the clipboard. Errorsoften occur when a staff member makes an assumption based on patientdemographics (e.g., age, sex, name, room number, etc.) versus primaryverification methods (e.g., checking wristband).

The current system allows the potential for documentation that allpatients on the unit had been visually observed as scheduled, when infact, an observation check may have been missed. In theory, staff couldbe non-conformant with protocol by documenting that all visualobservations had been completed, on schedule, without leaving thenurses' station, or without being on the unit and performing therequired visual assessment.

Unfortunately, with the current system, when a visual observation checkis missed or erroneously recorded there is no mechanism to alert thestaff member or unit personnel that the observation check was missed orincorrect. Typically, a missed or undocumented observation is discoveredafter the fact, upon review of the paper documentation, or upondiscovery of an adverse patient event. The charge nurse or unit managerwould not be immediately aware that visual observation checks were beingmissed as there is no mechanism for real time notification.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the presently disclosedsubject matter are described with reference to the following figures,wherein like reference numerals and/or indicia refer to like partsthroughout the various views unless otherwise precisely specified.

FIG. 1a is a block diagram of an electronic monitoring system usingvisual observation and radio frequency (RF) signals, in accordance withan embodiment of the disclosed subject matter.

FIG. 1b is a block diagram of an electronic monitoring system using lineof sight and infrared and/or laser, in accordance with an embodiment ofthe disclosed subject matter.

FIG. 2 is a plan view of an exemplary floor plan of a facility in whichan electronic monitoring system has been installed, in accordance withone or more embodiments of the disclosed subject matter.

FIG. 3a is a flow chart illustrating the process followed by an observerusing an electronic patient monitoring system, in accordance with anembodiment of the disclosed subject matter.

FIG. 3b is a flow chart illustrating the process followed by an observerusing an electronic patient monitoring system with GPS and inter-patientdistance monitoring, in accordance with an embodiment of the disclosedsubject matter.

FIG. 4 is a flow chart illustrating the functional operation of anelectronic monitoring system, in accordance with an embodiment of thedisclosed subject matter.

FIG. 5 is a top view of a patient identification tag that uses radiofrequency (such as Bluetooth or low energy Bluetooth technology), inaccordance with an embodiment of the disclosed subject matter.

FIG. 6 is a top view of an example of a radio frequency (such asBluetooth or low energy Bluetooth technology) circuit board which can beused for a patient identification tag, in accordance with an embodimentof the disclosed subject matter.

FIG. 7a is a view of a check-in login screen for an electronicmonitoring system, in accordance with an embodiment of the disclosedsubject matter.

FIG. 7b is a view of a patient check-in screen in an electronicmonitoring system, in accordance with an embodiment of the disclosedsubject matter.

FIG. 8a is a view of an observer login screen for an electronicmonitoring system, in accordance with an embodiment of the disclosedsubject matter.

FIG. 8b is a view of a patient list screen in an electronic monitoringsystem, in accordance with an embodiment of the disclosed subjectmatter.

FIG. 9a is a view of an administrator login screen for an electronicmonitoring system, in accordance with an embodiment of the disclosedsubject matter.

FIG. 9b is a view of a patient checkup history screen in an electronicmonitoring system, in accordance with an embodiment of the disclosedsubject matter.

FIG. 10 is a top perspective view of a clasp and partial portion of awristband, in accordance with an embodiment of the disclosed subjectmatter.

FIG. 11 is an exploded view of the clasp and partial portion of thewristband of FIG. 1, in accordance with an embodiment of the disclosedsubject matter.

FIG. 12 is a cross-sectional view of the clasp portion of FIG. 10 alongline A-A, in accordance with an embodiment of the disclosed subjectmatter.

FIGS. 13A-13G include top, bottom, back side, left side, right side,front side and a top perspective views of the non-retractable springslides of the non-retractable spring slide of FIG. 11, in accordancewith an embodiment of the disclosed subject matter.

FIGS. 14A-14H include top, bottom, back side, left side, right side,front side views and a top perspective view of the clasp top bodyportion along line B-B of the clasp of FIGS. 10 & 11, in accordance withan embodiment of the disclosed subject matter.

FIGS. 15A-15G include top, bottom, back side, left side, right side,front side views and a top perspective view of the clasp bottom bodyportion of the clasp of FIGS. 10 & 11, in accordance with an embodimentof the disclosed subject matter.

FIGS. 16A-16G include top, bottom, back side, left side, right side,front side exploded views and a top perspective view of the claspportion of FIGS. 10 & 11, in accordance with an embodiment of thedisclosed subject matter.

FIGS. 17A-17G include top, bottom, back side, left side, right side,front side views and a top perspective, cross-sectional view along lineC-C of the clasp portion of FIGS. 10 & 11, in accordance with anembodiment of the disclosed subject matter.

FIG. 18 is a chart showing the RFID signal strength as a function ofdistance from an RFID beacon, in accordance with an embodiment of thedisclosed subject matter.

FIG. 19 is a timeline showing the time a user has to respond to asoftware request received as a result of the proximity of a beacon andassociated clasp to a user with a mobile sensor device of FIGS. 10 & 11,in accordance with an embodiment of the disclosed subject matter.

FIG. 20 is a representation of the interaction of the two users of asystem in which embodiments of the clasp and wristband of FIGS. 10 & 11are used, in accordance with an embodiment of the disclosed subjectmatter.

FIG. 21 is a logic flow chart of a system algorithm used for makingdecisions that a patient wearing a beacon and clasp of FIGS. 10 & 11 areused, in accordance with an embodiment of the disclosed subject matter.

FIG. 22 is a combination block diagram of the electronic monitoringsystem using visual observation and RF signals from FIG. 1b and a flowchart illustrating the process followed by an observer to observe andmonitor one or more patients using an electronic patient monitoringsystem and decision making process, in accordance with an embodiment ofthe disclosed subject matter.

FIG. 23 is an extended combination block diagram of an electronicmonitoring system using visual observation and RF signals and a flowchart illustrating the process followed by an observer to observe andmonitor one or more patients using a hand-held device and the electronicpatient monitoring system and decision making process of FIG. 22, inaccordance with an embodiment of the disclosed subject matter.

FIG. 24 is a flow chart illustrating the process from FIG. 3a that isfollowed by an observer using an electronic patient monitoring systemshowing where an electronic patient monitoring system and decisionmaking process can be implemented in the process, in accordance with anembodiment of the disclosed subject matter.

FIG. 25 is a flow chart illustrating the process from FIG. 3b that isfollowed by an observer using an electronic patient monitoring systemwith GPS and inter-patient distance monitoring showing where anelectronic patient monitoring system and decision making process can beimplemented in the process, in accordance with an embodiment of thedisclosed subject matter.

DETAILED DESCRIPTION

One or more embodiments of the disclosed subject matter include (i.e.,comprise) a system that uses active radio frequency (RF) identification(RFID) technology to assess completion of, for example, but not limitedto, visual monitoring of patients in a psychiatric unit of a treatmentcenter or hospital. There are several main components to the visualmonitoring system, a patient identification device with a beacon thatemits a patient-specific signal, an observer transmitter/receiver (T/R)with specialized beacon signal detection and processing capabilitiesthat improve T/R system performance and a centralized software programfor data storage, monitoring and retrieval. Together, this system allowsfor visual observations of patients in an ethically responsible manner,while allowing for increased observation compliance from the currentpaper checklist system commonly employed. Other embodiments of thedisclosed subject matter can also include multiple fixed-position T/Rsthat are permanently affixed to walls or other structural features ofthe facility in predetermined positions. In other embodiments thebeacons in the identification devices can be configured to also receiveand then retransmit the received signals. The received signals canoriginate from other identification device beacons, as well as any T/Ror any computer in the system and the retransmitted signals can go tostill other identification device beacons, T/Rs and other computers inthe system. This can be used to implement a mesh networking system, suchas, for example, but not limited to, a Bluetooth mesh network, which hasbeen defined in a Bluetooth Mesh Profile Specification and a BluetoothMesh Model Specification on the Bluetooth website.

This application claims priority to U.S. Provisional Application Ser.No. 62/394,637, filed Sep. 14, 2016, which is hereby incorporated byreference herein in its entirety.

FIG. 1a is a block diagram of an electronic monitoring system usingvisual observation and RF signals, in accordance with an embodiment ofthe disclosed subject matter. In FIG. 1a , an electronic monitoringsystem 100 is illustrated that includes an active patient identification(ID) tag 110 that is connectible by radio frequency communication duringvisual observation with a generally mobile observer transceiver/receiver(T/R) 120 which serves as a power source and activates the activepatient ID tag 110 and is communicatively connected to a centralcomputer system 130 that has an electronic monitoring system softwareprogram 132 installed and running. The electronic monitoring system 100may optionally include one or more fixed location T/Rs 122 that is/arealso connectible by radio frequency during visual observation to andalso serve(s) as a power source to activate the patient identificationtag 110. Each fixed location T/R 122 is communicatively connected to thecentral computer system 130 and the electronic monitoring systemsoftware program 132. One or more workstations, for example, one or morenurses workstations 140 and/or one or more administrative/administratoror other workstations 142 may be locally and/or remotely connected tothe central computer system 130 and the electronic monitoring systemsoftware program 132. In addition, one or more PDA devices 150 may bedirectly or wirelessly connected to and access the electronic monitoringsystem software program 132. The software program 132 will take thetransmitted data and convert it to a digital display that shows, forexample, the patient identification, observation time, patient activityand the personal identification of the staff member who made the visualobservation. The digital display can be displayed on the observer'shandheld device as well as on the workstation and/or PDA trackingscreens. If a scheduled visual observation check is missed, an alarm(visual or by sound, for example) will appear on the screen of theobserver and at any workstation and/or PDA, such as a nurse'sworkstation 140. The system software 132 will also keep a permanentrecord of all observation histories that can be downloaded to anarchival database on a secure hospital server.

Patient Identification System. Using RFID or similar technology (e.g.,infra-red, Bluetooth, low-energy Bluetooth, etc.), patient informationincluding name, room number and other relevant information is stored ina passive or an active RFID electronic tag unique to and substantiallycontinuously attached to the patient through one of several means. Thetag can be attached to or implanted in a wristband worn by the patient.The tag can be a rigid chip or a flexible circuit board. Flexiblecircuit boards can be custom designed for the active signal and patientinformation storage using standard state-of-the-art technology. The tagcan also be attached or embedded in a garment or other tag or deviceworn, attached to or used by the patient. Some of the devices in whichthe tag can be located can include, but are not limited to, a helmet, aprosthetic device, a brace, a walker, a wheelchair, a necklace, etc.

FIG. 1b is a block diagram of an electronic monitoring system using lineof sight and infrared and/or laser, in accordance with an embodiment ofthe disclosed subject matter. In FIG. 1b , an electronic monitoringsystem 100′ is illustrated that includes a patient identification (ID)tag 110′ that is connectible by line-of-sight using infrared and/orlaser technology with a generally mobile observer transceiver/receiver(T/R) 120′ which serves as a power source and activates the patientidentification tag 110′ and configured to receive and store GPSsatellite positioning information from a GPS system 125′. The electronicmonitoring system 100′ may optionally include one or more fixed locationT/Rs 122′ and also serve(s) as a power source to activate the patientidentification tag 110′. The T/Rs 120′, 122′ can also be configured toreceive and store GPS satellite positioning information from a GPSsystem 125′ and are further communicatively connected to a centralcomputer system 130′ that has an electronic monitoring system softwareprogram 132′ installed and running. One or more workstations, forexample, one or more nurses workstations 140′ and/or one or moreadministrative/administrator or other workstations 142′ may be locallyand/or remotely connected to the central computer system 130′ and theelectronic monitoring system software program 132′. In addition, one ormore PDA devices 150′ may be directly or wirelessly connected to andaccess the electronic monitoring system software program 132′. Thesoftware program 132′ will take the transmitted data and convert it to adigital display that shows, for example, the patient identification,observation time, patient activity and the personal identification ofthe staff member who made the observation. The digital display can bedisplayed on the observer's handheld device as well as on theworkstation and/or PDA tracking screens. If a scheduled observationperiod is missed, an alarm (visual or by sound, for example) will appearon the screen of the observer T/R 120′ and at any workstation and/orPDA, such as a nurse's workstation 140′. The system software 132′ willalso keep a permanent record of all observation histories that can bedownloaded to an archival database on a secure hospital server.

FIG. 2 is a plan view of an exemplary floor plan of a facility in whichan electronic monitoring system has been installed, in accordance withone or more embodiments of the disclosed subject matter. In FIG. 2, afloor plan 200 of a facility is shown to include one or more observerswith T/R devices 210, one or more patients with ID tags 220, one or morefixed T/R devices 230, multiple patient rooms 240, a dining area 250, atleast one nurses station 260, a kitchen area 270, a laundry area 280, acommon room 285, and a hallway 290.

Patient information that can be stored on the patient RFID tag 110, 110′includes the patient's hospital identification number, name, diagnosis,risk factors, expected pulse rate and/or other physiological signals tomonitor, for example, specified levels of activity or rest. In addition,to the specific patient identification information associated with thetag, the system can monitor the patient's location within the facilityand/or in relation to other patients and/or observers.

Using radio waves, the patient's identification tag 110, 110′ can beactivated and then emit a signal that will be received by a T/R device120, 120′, which is carried or worn by the observer. The frequency ofthe radio waves can be in compliance with hospital or institutionspecifications including HIPAA regulations. The observer responsible forvisual patient monitoring at set intervals will carry or wear the T/Rdevice 120, 120′ that activates the patient RFID tag 110, 110′ when theT/R 120, 120′ device is within a given distance from the patient RFIDtag 110, 110′ using, for example, Bluetooth or low-energy Bluetoothdevices. This distance or range is adjustable via the adjustments to thetransmission signal and may be specified by a responsible treatment teamat a particular unit or hospital. The distance is controlled so that itis within a visible range of observer to patient. The patient RFID tag110, 110′ and T/R 120, 120′ will permit visual observations, and/orgeneral observations based on distance. The distance between theobserver and the patient could range with the capabilities of the RFsystem. In a typical example, the range would be less than 100 feet butcould be as small as one foot. The distance may be set to differentvalues for different observation situations. For example, duringsleeping hours, a close observation, say less than 10 feet, may beappropriate, whereas during waking hours, a greater distance, forexample, 10 to 25 feet, could be set. The distance can be set undercontrol of the central computer system. Further, the time interval canbe changeably set depending on circumstances such as time of day orchanging patient needs. The observer T/R device 120, 120′ may includeany personal digital assistant (such as an iPod, nook, iPhone, iTouch,droid, zigbee, etc) or a wrist display or badge display. For patienttracking, the fixed location T/Rs 122, 122′ operate in the same manneras the observer T/Rs with the exception that it is the patient'smovement to within a given, predefined distance from the fixed locationT/Rs 122, 122′ that causes the fixed location T/Rs 122, 122′ to activatethe patient RFID tag 110, 110′.

FIG. 3a is a flow chart illustrating the process followed by an observerusing an electronic patient monitoring system, in accordance with anembodiment of the disclosed subject matter. In FIG. 3a , the process isstarted 301 with an observer beginning their work shift and activating310 a T/R with pre-assigned patient ID numbers and round/visualobservation schedule. Prior to these steps, all patients being monitoredby the system are equipped 305 with an ID tag that contains informationspecific to each patient and, optionally, fixed position T/Rs can beaffixed 307 to walls and/or other parts of the facility in variouslocations in the facility. As the observer observes/interacts 315 withthe patients, the information from each patient's ID tag as well as thetime of the interaction and other patient-specific information areautomatically recorded. After a predefined time period, for example,immediately, every minute, etc., all information recorded by the T/R issent 320 to the central computer to be processed and stored. Forexample, the electronic patient monitoring system, which can beimplemented in a software program, will take the transmitted data andconvert it to a digital display that shows, for example, the patientidentification, observation time, patient activity and the personalidentification of the staff member who made the observation. The digitaldisplay can be displayed on the observer's handheld device as well as onthe workstation tracking screen. If a scheduled visual observation checkis missed within the given time interval, an alarm (visual or by sound,for example) will appear on the screen of the observer and at anyworkstation, such as a nurse's station. The software will also keep apermanent record of all observation histories that can be downloaded toan archival database on a secure hospital server. If a missed patientvisual observation check is detected 325, an alert is sent 330 to theobserver, the nurse's station, other observers, etc. and the observer isdirected to locate and observe/interact 315 with the missed patient. Ifthe patient visual observation check was detected 325, then the observerdetermines 335 whether there are additional patients to be observed. Ifthere are more patients to be observed, the observer is directed tolocate and observe/interact 315 with the next patient. If there are nomore patients to be observed, the observer is directed to deactivate 340the T/R and the observation process ends 399.

The RFID tag and T/R devices may be utilized at fixed locations withinthe unit or facility to monitor patient location, and permitnotification via warning light or alarm when patients or staff membersare near or have entered areas which have restrictions to access. TheRFID tag and observer's T/R device will also function mobily, which isnot dependent on a fixed location of service. Once the RFID tag isactivated, a signal is sent to the activating fixed location or observerT/R device. The T/R device registers the patient information from theRFID tag in software included in the observer T/R device. This includesan electronic checklist that ensures and documents the signal wasreceived in the given time requirement imposed by the treatment team orfacility guidelines.

Software in the T/R device, and at the central nurses' station, gives awarning signal (such as a yellow light or beep), if a patient has notbeen successfully visually observed within the given time intervalspecified by the patient's treatment team. This system presents theobserver with immediate feedback to go and check on the missed patient.The time interval may be scheduled as continuous (i.e., real time)monitoring, a predetermined number of minutes (e.g., every 1, 5, 10, 15or 30 minutes, or increments thereof), hourly monitoring or rounding,monitoring for a predetermined number of hours, or daily monitoring.After the patient has been identified, a note is made in the softwareand the process is reset to continue with normal monitoring. In additionto the patient-specific feedback, the system can also providestatistical compliance feedback to each observer of one or measures ofthe individual observer's performance. In general, this feedback can beprovided to each observer in real time, so the observers know exactlyhow they are performing at any given point in time, or at least withonly a minimal delay, for example, but not limited to, a few seconds.This can be used as a way to motivate each observer to, if necessary,self-correct to maintain their level of performance at or above thenecessary levels needed for compliance with the required observationschedules.

In addition to receiving and storing the patient information after thevisual observation has been made in the given distance from the patient,the observer T/R device automatically transmits the data wirelessly to acentralized software system. The data can also be incorporated into amore comprehensive electronic medical record.

Centralized Software Monitoring and Warning System. The T/R sends thevisual observation patient data to a centralized software systemwirelessly and in real time. The software stores the patientidentification documentation as collected by the T/R device.Additionally, the centralized software signals an alert (e.g., by lightor sound) when a patient observation is missed during a prescribed timeinterval and generates reports of documented observations.

The centralized software generates an alert of a missed patientobservation to, for example, but not limited to, immediately activateany identified camera systems within the assigned proximity of the unitor identified geographical region, activate an emergency response systemwhich may include automatically locking doors permitting outside access,activation of an overhead public announcement system to provideinformation and alarms, and a visual representation of the location ofall identified patients on the unit.

The centralized software can be accessed from a nurses' station in thepsychiatric unit, where the nurses' station attendants would also bealerted to any missed visual observation checks. This component to thesystem adds a secondary check to the observation system in addition tothe primary observer responsible for the visual checks. Now, a secondnurse or attendant at the nursing station could also be alerted in realtime that a patient observation has been missed.

The centralized software can create an alert (by light or sound) when apatient demonstrates a heightened pulse interval, as predetermined basedon clinical criteria.

FIG. 3b is a flow chart illustrating the process followed by an observerusing an electronic patient monitoring system, in accordance with anembodiment of the disclosed subject matter. In FIG. 3b , the process isstarted 301′ with an observer beginning their work shift and activating310′ a T/R with pre-assigned patient ID numbers and round/visualobservation schedule. Prior to these steps, all patients being monitoredby the system are equipped 305′ with an ID tag that contains informationspecific to each patient and, optionally, fixed position T/Rs can beaffixed 307′ to walls and/or other parts of the facility in variouslocations in the facility. The system (i.e., the central computer, T/Rs,and patient ID tags) can also be connected 309′ to and use GPS positioninformation. Alternatively, the system can use Bluetooth or low-energyBluetooth proximity and patient information that is exchanged betweenthe patient ID tag and the observer T/R. As the observerobserves/interacts 315′ with the patients, the information from eachpatient's ID tag as well as the time of the interaction and otherpatient-specific information are automatically recorded. After apredefined time period, for example, immediately, every minute, etc.,all information recorded by the T/R is sent 320′ to the central computerto be processed and stored. For example, the electronic patientmonitoring system, which can be implemented in a software program, willtake the transmitted data and convert it to a digital display thatshows, for example, the patient identification, observation time,patient activity and the personal identification of the staff member whomade the observation. The digital display can be displayed on theobserver's handheld device as well as on the workstation trackingscreen. If a scheduled observation period is missed, an alarm (visual orby sound, for example) will appear on the screen of the observer and atany workstation, such as a nurse's station. The software will also keepa permanent record of all observation histories that can be downloadedto an archival database on a secure hospital server. If a missed patientobservation time is detected 325′, an alert is sent 330′ to theobserver, the nurse's station, other observers, etc. and the observer isdirected to locate and observe/interact 315′ with the missed patient. Ifa missed patient observation time was not detected 325′, then theobserver determines 335′ whether there are additional patients to beobserved. If there are more patients to be observed, the observer isdirected to locate and observe/interact 315′ with the next patient. Ifthere are no more patients to be observed, the observer is directed todeactivate 340 the T/R and the observation process ends 399′.

In FIG. 3b , concurrently with and independently from the observerobservation process described above, the system can collect patientlocation information within the facility and determine inter-patientdistances to ensure minimum safe patient-to-patient distances aremaintained. After the process is started 301′, the system begins tocollect 350′ patient location information using the GPS or otherpositioning/tracking system, Bluetooth, low-energy Bluetooth proximityinformation, and/or fixed-position T/Rs. Once collected, the systemcalculates 352′ the inter-patient distances, which can include distancesbetween a patient and every other patient, a patient and only selectedother patients, distances between multiple (i.e., 3 or more) patients.This information can also be used to calculate a patient's or group ofpatients' position relative to restricted areas. After the inter-patientdistances are calculated 352′, the system determines 354′ whether any ofthe distances are less than a pre-defined minimum distance and, if not,the system returns to and continues to collect 350′ patient locationinformation. If so, the system alerts 356′ the patient's observer(s),the nurse's station and/or other observers and activates an alarm. Thesystem then determines 358′ whether the minimum distance has beenrestored and, if not, continues to determine 358′ whether the minimumdistance has been restored. If the minimum distance is determined 358′to have been restored, then the system deactivates the alarm 360′ anddetermines 362′ whether to continue to collect patient locations and, ifso, returns to and continues to collect 350′ patient locationinformation. If not, the patient location collection process ends 399′.

FIG. 4 is a flow chart illustrating the functional operation of anelectronic monitoring system, in accordance with an embodiment of thedisclosed subject matter. In FIG. 4, a flow chart 400 illustrating thefunctional operation of an electronic monitoring system software programis shown. Following start up 401 the program begins receiving 410patient-specific information from one or more observer T/R devices. Thisinformation is used by the program to determine 415 whether all patientshave been observed within the pre-specified time interval for eachpatient. If it is determined 415 that the patient was timely observed,the program determines based on the received patient information whetherthe patient is “out of bounds,” i.e., not in their approved area ofmovement, which may vary based on the time of day, and if out of bounds,or if it was determined 415 that the patient was not timely observed,the program sounds 425 an alarm and records the event. If the patientwas determined 420 to be “in bounds,” i.e., in their approved area ofmovement and/or a required distance away from other patients and/orareas, the system returns to receiving 410 patient information. After analarm is sounded 425, the observer responsible for the patient isnotified 430, a nurse's/attendant station is notified 435 andalternate/other observers are also notified 440 of the missed patientobservation. On the observer T/R device and nursing workstation (orother workstation) there would be an override which could only beaccessed via a password by approved override staff member. The staffmember could also code in the reason for override (for example, from adrop down menu). Once a signal has been received 445 to indicate thatthe patient has either been observed and/or is now in bounds, the alarmis cancelled 450 and associated information with the cancellation (e.g.,time of cancellation, ID of the observer that observed the patient,etc.) is recorded, the system returns to receiving 410 regularlyscheduled patient observation information.

Further, administrators could also monitor in real time observercompliance to help assess observer quality and to assess perturbationsin the process which make it more likely to miss a visual observation,such as a psychiatric counseling session or a medical test. This wouldallow the ability to fine-tune the observation system to better ensurethat a patient is monitored at all prescribed time intervals and tobetter prevent an adverse event (suicide or self-harming attempt) fromoccurring.

Hourly Rounding. Hourly rounding will be measured and documented by aRFID tag and T/R device in the same manner as previously described. Iftransmission is not made during the predetermined time interval a lightand/or audible alarm will be sounded by the centralized software area atthe nurses' station. Based upon a predetermined line of sight proximityan interaction time measurement will be monitored between caregiver andpatient to determine the interaction time between the participants foreach hourly rounding event.

The centralized software station will document the timeliness of eachcaregiver as they complete their hourly rounds, as well as theinteraction time spent with the patient within a predetermined line ofsight proximity. Interaction time indirectly provides information tobetter assist quality indicators of interaction directly relating topatient care and satisfaction.

Prevention of harm/inappropriate behavior. A measurement ofpatient-to-patient proximity can be obtained by for example, GPScoordinates or an active transmitter on each patient, for example, aBluetooth or low-energy Bluetooth device, that will signal when a givendistance would be achieved to ensure that an appropriate distancebetween patients is maintained. Based on a predetermined acceptabledistance of identified patients, hour of the day, or unit locationpatients determined to be at risk will trigger notification of thecentral software system via green, yellow or red light or audible alarmwhen identified patients are within a predetermined proximity asmeasured by RFID tag transmission

FIG. 5 is a top view of a patient identification tag that uses lowenergy Bluetooth technology, in accordance with an embodiment of thedisclosed subject matter. In FIG. 5, a patient identification tag 500includes a body portion 510 that is attached to a strap portion 520,which has multiple openings 522 defined in the strap portion 520. Thebody portion 510 includes a Bluetooth low energy (BLE) RFID beacondevice 530 that can transmit a signal having a 360° range of about 10 to20 feet from the device. A battery holder 540 is also attached to thebody portion 510 and is configured to receive and hold a flat battery(not shown) and is electrically connected to a BLE RFID beacon device530. The body portion 510 also includes a top flange 512 on which arelocated a pin 514 that is positioned and configured to fit within theopenings 522 on the strap portion 520. An opening 516 is formed in thetop flange 512 adjacent the pin 514 and has a grommet 517 securelyfastened within the opening 516 and the grommet 517 is configured to fitonto and securely hold the pin 514 after the identification tag 500 hasbeen placed around a patient's wrist and one of the opening 522 on thestrap portion 520 have been fitted over the pin 514.

FIG. 6 is a top view of a flexible Bluetooth low energy circuit boardfor use in a patient identification tag, in accordance with anembodiment of the disclosed subject matter. In FIG. 6, an example of aflexible active circuit board 600 that includes the transmissioncomponents and patient identification data is illustrated.

FIG. 7a is a view of a check-in login screen for a user device in anelectronic monitoring system, in accordance with an embodiment of thedisclosed subject matter. In FIG. 7a , a screen 700 is displaying alogin screen that includes a username entry box 710 and password entrybox 720, a login selection button 730, a return icon 702, a movementicon 704 and a page change icon 706. The username entry box 710 isconfigured to receive a check-in user name and the password entry box720 is configured to receive a check-in password associated with thecheck-in user name and the login selection button 730 is configured tobe selected after the user name and password have been entered and topass control to the program to determine whether the correct user nameand password combination were entered and to determine what informationand user rights are associated with the user name and password and themdisplay that information on the screen, for example, as shown in FIG. 7b. When selected, the return icon 702 displays the prior screeninformation, the movement icon 704 permits a user to scroll up and downdepending on the amount of information on each page and the currentposition in the information on the page, and, if more than one page ofpatient information is associated with the patient, the page change icon706 permits a user to move forward and backward through the pages.

FIG. 7b is a view of a patient check-in screen in an electronicmonitoring system, in accordance with an embodiment of the disclosedsubject matter. In FIG. 7b , a patient check-in screen 700′ is shown toinclude a picture of a patient 710′, an add picture button 715′, a firstname input box 720′, a last name input box 730′, a check-up intervalinput box 740′, a room number input box 750′, a patient ID input box760′, a device ID input box 770′, a scan device barcode selection button780′, an add patient selection button 790′, the return icon 702, themovement icon 704 and the page change icon 706. When the add picturebutton 715′ is selected a picture of the patient may be added by, forexample, but not limited to, taking a picture with a camera that is partof, connected to or associated with the user device, downloading thepicture from a storage device that is connected to the user device, etc.When the scan device barcode selection button 780′ is manually selected,the user device will scan the barcode associated with the patient'sidentification tag. Alternatively, in embodiments of the disclosedsubject matter that use the BLE RFID tags, selecting the scan devicebarcode selection button 780′ would cause the user device to read theRFID device number associated with the patient's ID tag. Still further,the user device could automatically detect a signal from and read theRFID device number associated with the patient's ID tag when the userdevice comes within the transmit range of the RFID device.

FIG. 8a is a view of an observer login screen for a user device in anelectronic monitoring system, in accordance with an embodiment of thedisclosed subject matter. In FIG. 8a , a screen 800 is displaying alogin screen that includes an observer's username entry box 810 andpassword entry box 820, a login selection button 830, a return icon 802,a movement icon 804 and a page change icon 806. The username entry box810 is configured to receive an observer's user name and the passwordentry box 820 is configured to receive an observer password associatedwith the observer's user name and the login selection button 830 isconfigured to be selected after the observer's user name and passwordhave been entered and to pass control to the program to determinewhether the correct observer's user name and password combination wereentered and to determine what information and user rights are associatedwith the observer's user name and password and them display thatinformation on the screen, for example, as shown in FIG. 8b . Whenselected, the return icon 802 displays the prior screen information, themovement icon 804 permits a user to scroll up and down depending on theamount of information on each page and the current position in theinformation on the page, and, if more than one page of patientinformation is associated with the patient, the page change icon 806permits a user to move forward and backward through the pages.

FIG. 8b is a view of a patient list screen in an electronic monitoringsystem, in accordance with an embodiment of the disclosed subjectmatter. In FIG. 8b , a patient list screen 800′ is shown to includemultiple patient information summaries 801′ that each display a pictureor generic silhouette of a patient 810′, a last and first name of thepatient 812′, a room number 814′, a last name input box 816′, a signalstrength indication 818′, a time remaining to observe 819′, the returnicon 702, the movement icon 704 and the page change icon 706. When theobserver comes within range of each patient's RFID tag, the deviceautomatically detects the signal and reads the RFID device numberassociated with the patient's ID tag as well as any other pertinentpatient data, for example, vital statistics, actual location, activity,etc. As seen in FIG. 8b , a first patient information summary 801′ for“Dolhansky, Brian” is highlighted to indicate that the requiredobservation time has passed (note the 0 minutes value displayed for thetime remaining to observe 819′) and that no actual observation of thepatient has been recorded.

FIG. 9a is a view of an administrator login screen for a user device inan electronic monitoring system, in accordance with an embodiment of thedisclosed subject matter. In FIG. 9a , a screen 900 is displaying alogin screen that includes an administrator's username entry box 910 andpassword entry box 920, a login selection button 930, a return icon 902,a movement icon 904 and a page change icon 906. The username entry box910 is configured to receive an administrator's user name and thepassword entry box 920 is configured to receive an administratorpassword associated with the administrator's user name and the loginselection button 930 is configured to be selected after theadministrator's user name and password have been entered and to passcontrol to the program to determine whether the correct administrator'suser name and password combination were entered and to determine whatinformation and user rights are associated with the administrator's username and password and them display that information on the screen, forexample, as shown in FIG. 9b . When selected, the return icon 902displays the prior screen information, the movement icon 904 permits auser to scroll up and down depending on the amount of information oneach page and the current position in the information on the page, and,if more than one page of patient information is associated with thepatient, the page change icon 906 permits a user to move forward andbackward through the pages.

FIG. 9b is a view of a patient checkup history screen in an electronicmonitoring system, in accordance with an embodiment of the disclosedsubject matter. In FIG. 9b , an administrative utilities screen 900′ isshown to include a received signal strength indication (RSSI) Thresholdvalue 910′, a listing of available devices section 920′ with informationfor each device including a device address 922′, a device RSSI 924′ anda paired patient name 926′, and a patient checkup history section 930′with separate information for each patient that includes a requiredpatient observation time 933′, an actual patient observation time 935′and an assigned observer name for the patient 937′.

FIG. 10 is a top perspective view of a clasp and partial portion of awristband, in accordance with an embodiment of the disclosed subjectmatter. In FIG. 10, a wristband and clasp system 1000 includes atamper-resistant wristband band material 1005 and an assembled clasp1001 that holds two ends of the wristband 1005 together securely on aperson's wrist, for example, but not limited to, the wristband 1005 canbe a woven band ¾ inch wide by 0.040 inch thick, which has a pluralityof openings 1006 formed there through and adjacent to each end 1008 ofthe wristband 1005. The clasp includes four parts: a top portion 1010, abottom portion 1020 (see FIG. 11) and two non-retractable spring slides1022 (see FIG. 11), which can be pre-assembled and retained in oppositelongitudinal grooves 1024 in the body of the bottom portion 1020.

FIG. 11 is an exploded view of the clasp and partial portion of thewristband of FIG. 10, in accordance with an embodiment of the disclosedsubject matter. In FIG. 11, the clasp 1010 has a number of features thatmake it highly resistant to tampering once it is assembled. In general,the clasp parts can be made of plastic, composite, metal or somecombination of dissimilar materials although the clasp embodiment shownin the figures has a special advantage of having an all-plasticconstruction. Non-metal parts are preferred and required in manysettings such as corrections facilities where metal parts can beweaponized in some improvised fashion. However, plastic is orders ofmagnitude less stiff than metal so it presents special challenges formaking tamper resistant clasps. Embodiments of the disclosed subjectmatter overcome the inherent limitation of plastic parts in making atamper resistant clasp by virtue of several key features. For example,the top portion 1010 of the clasp 1001 surrounds the bottom 1020 of theclasp 1001 and wristband 1005 on five sides. Once snapped into place,the top portion 1010 of the clasp 1001 also fits very tightly over therest of the assembly such that there are no visible gaps at theintersections of the clasp parts or wristband exits. Having five sidesto the top portion 1010 of the clasp 1001 greatly increases itsstiffness and resistance to deformation and failure from prying tools.This added stiffness is especially important with plastic parts sincetheir resistance to deformation is much lower than with metal parts.Having five sides to the clasp top also forces the wristband 1005 tohave a more tortuous path before it exits the body of the assembledclasp. As shown in FIG. 11, having side four 1017 and side five 1019 onthe top portion 1010 of the clasp 1001, forces the wristband to have twobends 1007 prior to exiting the assembled clasp 1001. This tortuous pathprevents a prying tool from entering deep into the center of the clasp1001 and gaining substantially more leverage to break or deform theclasp 1001. The sloping surface 1023 of the bottom portion 1020 of theclasp 1001 also forces the wristband 1005 to snuggly conform to theclasp 1001 with no visible gaps which further prevents tools frompenetrating deep into the clasp 1001 to gain pry leverage. The two bends1007 in the wristband's 1005 path shortens the lever arm a pry tool has,which greatly increases tamper resistance.

In FIG. 11, two recessed clips 1025, each with a pair of flexible fingerelements 1026 with inwardly flanged ends 1026 a, are formed on themiddle edge and on opposite sides of the top side of the bottom portion1020. The recessed clips 1025 are configured to receive and slidinglyconnect to an anchor post 1022 c on the top of each non-retractablespring slide 1022 when the non-retractable spring slides 1022 are pushedinto the opposite longitudinal grooves 1024. Similar to the flexiblefinger element inwardly flanged ends 1026 a, the anchor posts 1022 chave outwardly flanged ends 1022 f, which are configured to slidinglyengage the flexible finger elements 1026 of the non-retractable springslides 1022, but not be removable from the recessed clips 1025. Theanchor posts 1022 c on the top of each non-retractable spring slide 1022clip are configured to slide between the flexible finger elements 1026and mate into the recessed clips 1025, To facilitate this mating theleading, outer edges of the anchor posts 1022 c are angled and theflexible finger element flanged ends 1026 a are vertically chamfered tomeet the angled, leading, outer edges of the anchor posts 1022 c to helppush the flexible fingers 1026 apart and permit the flanged end 1022 fof the anchor posts 1022 c to push through and into the recessed clips1025 and are prevented from being removed by the inwardly flanged ends1026 a of the flexible fingers 1026. The two non-retractable springslides 1022 act as locking devices to hold the clasp mechanism togetherwhen the bottom portion 1020 is inserted into the top portion 1010 ofthe clasp 1001. The wristband 1005 can be used to hold an RFID orbiosensor beacon, for example, but not limited to, the RFID beacondevice 530 discussed above in relation to FIG. 5, on a person's wrist.The beacon device 530 can slide onto or otherwise be fastened to theband in such a way that it cannot be removed without destruction of thewristband, clasp and/or beacon.

There are many settings where patients or other internees must wearwristbands for a variety of reasons but the patients are non-compliantor will remove, alter or destroy a typical wristband. In thesesituations, a tamper-resistant wristband, as shown in FIGS. 10 and 11,is needed. One or more embodiments of the disclosed subject matteraddress the need for a wristband 1005 that can be worn in an inpatientsetting such as a psychiatric hospital, correctional facility or anyfacility where there is a need for a tamper-resistant wristband that canonly be removed destructively. In other words, the wristband has aone-time use. Wristbands are needed for patient identification purposesor to attach RFID, biosensor or other types of wearable electronicbeacon devices 530. Such inpatient facilities typically also restrictthe use of metal components because of the potential for improvisedweaponization or self-harm. Therefore, there further exists a need for atamper-resistant wristband made entirely or largely out of plastic ornon-metallic materials, especially the wristband 1005 and clasp 1001used to secure the wristband 1005 ends. Embodiments of the disclosedsubject matter deal with a tamper-resistant one-time use disposableclasp 1001 that typically must be removed by cutting the wristband 1005,which is also disposable and one-time use.

There are numerous situations where it is useful to be able to attach aband or strap onto a person's wrist or ankle and have it be impossiblefor them to remove it without cutting the strap. Hospitals, securityfacilities, and other secure areas use bracelets or bands that achievethis. However, most existing designs can be opened with basic tools suchas a screwdriver or kitchen utensil. Embodiments of the disclosedsubject matter describe a one-time use clasp 1000 that cannot be openedwith basic or improvised tools.

For example, the user puts the preassembled bottom portion 1020 of theclasp 1001 on the wearer's wrist. The strap 1005 with pre-punched holes1006 is sized and placed onto multiple security pins 1021 located on atop side of the bottom portion 1020. The person applying the device thenpresses the top housing onto the top and optionally trims any excessband material 1005. During closure, the pathway of the clasp tightensthe band slightly due to the jogs in the path.

The clasp 1001 has three major security features. The first is that thetop portion 1010 of the clasp 1001 surrounds the bottom portion 1020 ofthe clasp 1001 on five sides. This provides additional strength to thedesign. The second feature is that the path that the band takes is notstraight. There is at least one bend, and preferably two bends in thispath. This prevents tools from entering the core of the clasp. The thirdfeature is that the slides that engage when the clasp is closed areseparate or integrated features that are spring loaded andnon-retractable. These slides can be spring loaded with plastic or metalspring features.

In some embodiments, the top portion 1010 of the clasp 1001 can betethered to the bottom portion 1020 of the clasp 1001. The slides aregenerally pre-assembled to the bottom portion 1020 of the clasp 1001.

The current embodiment also has a near zero force required for closingand securing the clasp. The design also requires almost no training.Both of these requirements are critical for the clasp is used widelywith a wide range of human capabilities (hand size and strength,aptitude, etc.).

In FIG. 11, once the beacon device 530 is slid onto or attached to thewristband 1005, the bottom portion 1020 is attached to the wristband1005 by placing the plurality of openings 1006 at each end 1008 of thewristband 1005 over the mounting/security pins 1021 on the top of thebottom portion 1020. Then the bottom portion and wristband 1005 areattached to the top of the clasp 1010 by inserting the bottom portion1020 of the clasp 1001 into the top portion 1010 of the clasp 1001 sothat the mounting/security pins 1021 engage and fit into a plurality ofreciprocally-shaped mounting holes 1011 in the bottom of the top surfaceof the top of the clasp, which is best seen in FIG. 12, and which slideonto the mounting/security pins 1021 on the bottom of the clasp.Returning to FIG. 11, the wristband 1005 with beacon device 530 andpre-assembled bottom portion 1020 is placed on the person's wrist andfastened on the wrist by wrapping the loose end of the band over themounting/security pins 1021 and snapping the top portion 1010 in placeso that the spring slides permanently lock into place in the top portion1010. When the current embodiment of the clasp, which uses the pins 1021to engage the openings 1006 in the wristband 1005, is exposed to >350lbs., the clasp 1001 remains undamaged and retains its closure. Thewristband 1005 can only be removed from the wearer's wrist by cuttingthe band or otherwise destroying the band, clasp and/or beacon.

Embodiments of the wristband 1005 can be composed of any organic,inorganic or combination of dissimilar materials. However, forcontrolled environments such as inpatient psychiatric hospitals andcorrections facilities where metal tools are not present, the bandmaterial is designed to resist chewing, tearing, abrasion, ordestruction by improvised tools. Polyester, Kevlar or some combinationof polymer materials in a variety of woven, knitted configurations,injection molding and/or implant molding can be used as the wristbandmaterials. The wristband 1005 can also be made of metal or dissimilarmaterials where one of the components is metal. However, metal canintroduce additional risks for self-harm by certain populations wearingthe wristband. The wristband can be universally sized to fit a widedistribution of wrist and ankle sizes. Although a variety of means canbe used to secure the wristband 1005 to the clasp 1001, in the currentembodiment in FIG. 11, the wristband 1005 has the plurality of holes1006 punched in both ends of the band for mounting over themounting/security pins 1021 on the bottom portion 1020 of the clasp1001. The other end typically has many holes to allow for customizedsizing to the wearer's extremity. Typically, once the band 1005 is sizedto the wearer, the excess band material is cut flush with the edge ofthe assembled clasp 1001.

As seen in FIG. 11, the two sides 1017, 1019 where the wristband 1005exits the clasp 1001 force the wristband 1005, in the current embodimentto have two bends 1007 prior to exiting the clasp. This tortuous,in-direct path greatly shortens the lever arm that a pry tool has toforce open the clasp 1001. In addition, there are zero gaps at allmating intersections of the parts and wristband. This makes it moredifficult for tools to enter especially an improvised tool where a verythin and stiff tool would be needed. Sloped surfaces 1014 (see FIGS. 14Aand 14H), 1023 on the top portion 1010 and the bottom portion 1020,respectively, of the clasp 1001 help to form the bends 1007 in thewristband 1005 and to tightly conform to the wristband's 1005 paththereby preventing gaps for a tool to penetrate.

In FIG. 11, as well as in FIG. 12, the non-retractable spring loadedslides 1022 that can be integrated and/or pre-assembled into theopposite longitudinal grooves 1024 formed in the sides of the bottomportion 1020 of the clasp 1001, which engage slots or indents 1013 inthe inside of the longitudinal side walls 1016, 1018 of the top portion1010 of the clasp 1001. Spring arms 1022 b of the non-retractable springloaded slides 1022 provide spring loading forces to bias or push theslides 1022 away from the opposite longitudinal grooves 1024 formed inthe sides of the bottom portion 1020 and toward the slots orindentations 1013 formed in the sidewalls of the top portion 1010 of theclasp 1001. In addition to locking the clasp 1001 together, this helpsto block any pry tool entry and to stay engaged with the top portion1010 of the clasp 1001 even with some deformation of the top portion1010 of the clasp 1001.

In this embodiment, the clasp is design as an integrated disposablebeacon device 530 housing, which permits the disposable beacon device530 to be combined with the clasp 1001. For example, but not limited to,the integrated disposable beacon device 530 can be water-resistant to >1meter static water pressure, crush proof to >500 lbs., and impact anddrop resistant.

Embodiments using this design are especially effective for anall-plastic clasp since plastic parts are much less stiff than metalparts and are therefore inherently harder to make into atamper-resistant clasp. In addition, metal is also banned or restrictedin many settings such as Corrections or psychiatric facilities, so allplastic clasps are needed.

FIG. 12 is a cross-sectional view of the clasp portion of FIG. 10 alongline A-A, in accordance with an embodiment of the disclosed subjectmatter. In FIG. 12, the latitudinal cross-sectional view shows theengagement of the components of an assembled clasp. For example, one ofthe mounting or security pins 1021 is seen inserted into one ofreciprocally-shaped mounting holes 1011 that are formed in an undersideof the top portion 1010 of the clasp 1001. In addition, a cross-sectionof the wristband 1005 is seen between the underside of the top portion1010 and a top side of the bottom portion 1020 with an open area 1012between the underside of the top portion 1010 and a top side of thewristband 1005. This open area 1012 is used to provide space for thebeacon device 530.

As seen in FIG. 12, an outer leg portion 1022 a of each of the twonon-retractable spring slides 1022 are engaged in the slots orindentations 1013 formed in the inside of the sidewalls 1016, 1018 ofthe top portion 1010 and in the opposite longitudinal grooves 1024formed in the sides of the bottom portion 1020 to lock the clasp 1001and wristband 1005 together. The non-retractable spring slides 1022block a pry tool from penetrating deep into the clasp and gainingleverage to deform or break the clasp. The spring-loaded aspect of thenon-retractable spring slides 1022 forces the non-retractable springslides 1022 to stay retained and engaged with the walls of the topportion 1010 of the clasp 1001 even if there is some deformation of thetop portion 1010. In embodiments of the disclosed subject matter, thenon-retractable spring slides can span the length of top portion 1010wall in a contiguous fashion or as a series of independent, discretefeatures.

FIGS. 13A-G show top, bottom, back side, left side, right side, frontside and a top perspective views of the non-retractable spring slide ofthe non-retractable spring slide of FIG. 11, in accordance with anembodiment of the disclosed subject matter. In FIGS. 13A-G, spring arms1022 b are seen extending outwardly away from opposite outer edges of abody portion 1022 d of the non-retractable spring slide 1022 and thencurving inwardly toward each other to form an arced shape with an openarea between inner ends of each spring arm 1022 b. In addition, theouter leg portion 1022 a of each non-retractable spring slide 1022 issized and configured to fit into one of the slots or indents 1013 formedin the inside of the longitudinal walls 1016, 1018 of the top portion1010 of the clasp 1001. As noted above, the non-retractable springslides 1022 act to lock the top portion 1010 and the bottom portion 1020of the clasp together and prevent efforts to separate the two oncelocked together to form the clasp 1001.

FIGS. 14A-H includes top, bottom, back side, left side, right side,front side views, a longitudinal cross-sectional view along line B-B anda top perspective view of the clasp top body portion of the clasp ofFIGS. 10 & 11, in accordance with an embodiment of the disclosed subjectmatter. In FIGS. 14A-H, the reciprocally-shaped mounting holes 1011 inthe bottom of the top surface of the top portion 1010 of the clasp 1001can be best seen in FIGS. 14A, 14G and 14H. In addition, how the fivesides of the top portion 1010 are configured to connect to the bottomportion 1020 and prevent tampering is best seen in FIG. 14G.Specifically, in FIGS. 14D, 14E and 14G, it can be seen how the bottom,inside surfaces 1016 a, 1018 a of the longitudinal sidewalls 1016, 1018are configured to abut the longitudinal sides of the bottom portion 1020and form a smooth, outside bottom surface of the clasp 1001 that isresistant to tampering and efforts to open the clasp 1001.

FIGS. 15A-G includes top, bottom, back side, left side, right side,front side views and a top perspective view of the clasp bottom bodyportion of the clasp of FIGS. 10 & 11, in accordance with an embodimentof the disclosed subject matter. In FIG. 15A, a top view of a bottomside 1028 of the bottom portion 1020 is shown. In FIG. 15G, the flexiblefingers 1026 and inwardly flanged ends 1026 a of the flexible fingers1026 are more clearly shown.

FIGS. 16A-G includes top, bottom, back side, left side, right side,front side exploded views and a top perspective exploded view of theclasp portion of FIGS. 10 & 11, in accordance with an embodiment of thedisclosed subject matter. In FIG. 16A-G, the different views of theclasp 1001 are shown without the wristband 1005 to more clearlyillustrate the configuration and assembly of the clasp 1001.

FIGS. 17A-G includes top, bottom, back side, left side, right side,front side views and a top perspective, cross-sectional view along lineC-C of the clasp portion of FIGS. 10 & 1, in accordance with anembodiment of the disclosed subject matter. In FIGS. 17A-G, the clasp1001 is shown fully assembled, but without a wristband 1005. In FIGS.17A-F, the top, bottom, back side, left side, right side, front sideviews of the assembled clasp 1001 are shown. FIG. 17G is partial cutawayview of FIG. 17C along line C-C to show the inner configuration andinterrelationships between the top portion 1010, the bottom portion 1020and the non-retractable spring slides 1022.

As previously discussed, RF signals are often used in a variety ofconfigurations to determine the relative or absolute position of one ormore objects, people or things. Position can be determined bytriangulating signal strengths amongst a collection of transceiverswhose position is known. Infrared or ultrasound signals can also be usedin a similar fashion or in combination with RF. Typically, thesetechnologies create a probability of location or proximity due to thevariability of such signals, which can result in poor systemperformance, response times and efficiencies. However, these systems arecomplicated and expensive because they involve some degree ofinfrastructure, calibration and maintenance.

Therefore, there exists a need for a simpler means of determining theproximity between two or more objects, people or things where each ofthe entities has a transmitter, receiver or transceiver. The twoentities can be mobile and/or stationary. However, radio frequencysignals are inherently variable due to direct and multipathtransmissions. This inherent variability complicates any correlationbetween RF signal strength and proximity (distance) especially iftriangulation is not being used and the measurements are point-to-pointbetween User and patient. If the transmission rate of the RF signal isseconds or milliseconds and you are relying on a threshold signalstrength to have a person make a decision, as opposed to software makingthe decision, via some visual or audio trigger, the threshold level canchange too rapidly not only for a person to make a decision, but to evenbe notified that a decision needs to be made. This is especially true ifthe user has multiple patients/beacons to monitor via visual or audiotriggers.

Two known techniques used to address such signal variability and set thethreshold value include: averaging a group of signals; and binning agroup of consecutive signals and selecting the maximum signal from thatbin. Averaging and binning have a common problem when you are relying ona human user to react (make a decision) to a direct or softwaregenerated request for action. By definition these techniques usehistorical or past information. When using historical information, thesystem cannot rely on a human user to wait or stay on station with theirpatient until the request for action comes through again, because theuser may have moved on from the patient to another patient or thepatient may have moved away from the user. This is especially true, ifthe RF signal levels are highly variable compared to the optimal timeneeded for the human user to take a requested action. Regardless,processor and system performance can be degraded or inhibited due to theuse of historical data that opens an entry window for a patient that theuser has already moved past or has moved away from the user, so it notwould be a valid observation entry. Fortunately, this would not preventthe user from entering information for another patient that the user isactually observing, but the user would have to be and remain in range ofand receive a beacon signal from the other patient to give the processortime to determine proximity and open a window for the other patient. Asa result, not only is the system wasting processing resources waitingfor information on the past patient, but making the user wait for thesystem to catch up and detect the other patient actually being observedby the user. Not only does this waste processor/system resources it alsowastes human resources in a setting that cannot afford to beinefficient.

In embodiments of the disclosed subject matter, this problem is solvedby having the system software detect when the RF signal threshold levelhas been reached indicating that a patient is in range of a T/R and thenhold the visual or audio cue for some predetermined/predefined period oftime so that the user of the T/R has sufficient time to make a decision.In other words, embodiments of the disclosed subject matter do not relyon historical data.

FIG. 18 is a chart showing the RFID signal strength as a function ofdistance from an RFID beacon, in accordance with an embodiment of thedisclosed subject matter. RF signals traveling to an RF receiver vary inintensity as shown in FIG. 18. There will be a maximum level of signaltransmission strength 1800 that forms an envelope 1801 over manytransmission points that vary in intensity. The maximum signaltransmission strength 1800 points can be correlated to proximity betweentransmitter and receiver. Knowing this correlation, one can select athreshold signal strength approximately equal to the maximum level ofsignal transmission strength 1800 to determine an approximate proximity.However, as shown in FIG. 18, measurement of the signal strength can beunstable due to the multipath points. Multipath signals typically arenot direct line-of-sight signals, which represent a maximum signal leveland which forms the maximum signal transmission strength 1800 envelope.Multipath signals 1801 reflect off one or more surfaces before hittingthe signal receiver where their power level is registered. Attempting touse the maximum signal level to trigger a visual or audio cue ordecision request for a user, will likely not provide the user withenough time to take the requested action, especially if the time torespond is tied to the duration of maximum signal since the thresholdlevel will be unstable and brief. As a result, the system will beinefficient and waste system processing resources due to useless contextswitching cycling back and forth from a received signal that exceeds thesignal threshold to one that does not exceed the signal threshold. Thiscan occur, because turning on the system's ability to accept a requiredinput from the user after receiving a signal that exceeds the thresholdvalue to then turning it off as soon as the next signal is received thatis below the threshold level. In addition, due to the short time betweentransmission of the individual signals, the amount of time a user wouldhave to make the necessary entries

In embodiments of the disclosed subject matter, this problem is solvedby presenting the user with the decision request for apredetermined/predefined period of time (ΔT) that is typically longerthan the duration of time where the maximum signal level is present, asshown in FIGS. 18, 19 and 21. FIG. 19 is a time line showing the time auser has to respond to a software request received as a result of theproximity of a beacon and associated clasp to a user with a mobilesensor device of FIGS. 10 & 1, in accordance with an embodiment of thedisclosed subject matter. In FIG. 19, once a beacon signal exceeds thethreshold level (X), the software presents the user with a request foraction for a time interval equal to the beacon signal advertisement timeinterval Y and an additional predetermined/predefined time interval K.Time interval K can be set to be equal to or greater than the minimumperiod of time for a user to respond to a software or direct (digital oranalog direct sensor feedback) request for action via some visual oraudio trigger. In addition, time interval K can also be set as amultiple of the beacon signal time Y, or the beacon signal time Y plus apredetermined/predefined time period that has been specified and/ordetermined to be a minimum and/or average time that is needed for theuser to recognize the alert and enter the necessary information for theidentified patient into a portable device, for example, but not limitedto, the observer T/R 120, the central computer 130, and the PDAs 150.

In FIG. 19, if the system were to only permit the user to respond duringthe time of the signal detection, the system would become inefficientand/or unusable. For example, as discussed above and seen in FIG. 18,and as seen here in FIG. 19, because of the inherently variable natureof RF signals due to the direct and multipath transmissions, it is notuncommon to not receive continuous RF signals that exceed the thresholdlevel. As a result, the system processor can start context switchingcycling when it receives a signal with RF greater than or equal to(i.e., “>=”) X and sends out a request to the user, but then the next RFsignal received is NOT>=X, so the system immediately closes out therequest and either won't accept any input from the user or only receivea partial input. If this continues to happen, the processor will beginto become inefficient and potentially get caught in extended or endlesscontext switching loops during which time, nothing can be entered intothe system. If the signal advertisement time is short enough, forexample, only milliseconds or seconds, and there is not a continuousstream of signals with RF>=X in continuous advertisement periods, then,the system either may not have enough time to display the request or therequest may be displayed, but then it is revoked before the user can seeit and/or respond to it. If any of these situations occur, the systemcan become so inefficient that it is only barely useable or not useableat all. As described below, embodiments of the disclosed subject matterhelp resolve this system performance problem.

FIG. 20 is a representation of the interaction of the two users of asystem in which embodiments of the clasp and wristband of FIGS. 10 & 11are used, in accordance with an embodiment of the disclosed subjectmatter. For example, in FIG. 20, the maximum signal level 2004 beingsent by a beacon 2003 on a patient, may only be present for millisecondsor seconds but, regardless, it is much less time than is needed for thesoftware in a mobile device 2002, for example, but not limited to, aPDA, to present a request for action to a user and then for the user torespond to the requested action. However, by presenting and holding openthe request for action for an extended period, for example, but notlimited to, K+Y time, the user will have adequate time to respond. Whilethis novel methodology can be used with any kind of RF, infrared orultrasound signal, it is especially useful under the followingconditions. The embodiment in FIG. 20 can use standard off-the-shelfmobile devices that have the built-in ability to receive Bluetoothsignals and no need for multiple facility based Wi-Fi-Bluetoothtransceivers to measure and relay proximity information. As a result,not only is the necessary system hardware simplified, but the signaldetection and processing is simplified, which results in a moreefficient and responsive system.

The RF in FIG. 20 can be Bluetooth and the user (e.g., a human) ismaking a decision rather than the software. The user is using a mobiledevice to directly interrogate multiple patient beacons each with aunique Bluetooth address. However, the user is not “linking” with eachbeacon for which it receives a signal 2004. Instead, the user is simplymeasuring the strength of each beacon's received advertising signalagainst the RF threshold value 1801 to determine proximity to thatparticular patient.

In other embodiments of the disclosed subject matter, the interrogationof the patient beacons via a mobile device can also be indirect. Thatis, a series of Bluetooth or RF receivers can be positioned in afacility, room or chokepoint to collect the patient's Bluetooth signaland determine the patient's position relative to a user with a mobiledevice. The User and patient's position can be reported via Wi-Fi.

The algorithm or logic for determining when a patient is in range andthereby modifying the user's mobile/PDA display accordingly can beexecuted on the mobile/PDA application software. However, the algorithmcan also be executed in a central server or a Cloud server and theuser's display changed via commands delivered to it via Wi-Fi.

FIG. 21 is a logic flow chart of a system algorithm used for makingdecisions that one or more patients wearing a beacon and clasp of FIGS.10 & 11 are within range of an observer's signal detection andinformation recordation device, in accordance with an embodiment of thedisclosed subject matter. In FIG. 21, a process 2100 for detecting abeacon advertisement signal begins 2105 and sets 2110 a proximity RFthreshold level to a value X where any detected signals greater than orequal to X will be considered to be “in range”. The process continuesand measures 2120 the level of a received RF signal and then determines2130 whether the received RF signal is greater than or equal to thethreshold level X (i.e., RF>=X). If RF<X, then the process loops back tomeasure 2120 a next received signal. If it is determined 2130 that theRF>=X, then, the system presents 2140 the user with a visual or audiocue or action request for an extended period of time Δt that exceeds theadvertisement period of the detected signal for which RF>=X. The systemthen determines 2150 whether the user responds with the informationbefore the end of the extended period of time Δt. As described above,each signal is associated with a specific patient, so the informationrequested is for the patient associated with the detected signal. If itis determined 2150 that the user does NOT respond before the end of theextended period of time Δt with the information for the patientassociated with the detected signal, then the process returns tomeasuring 2120 the received RF signals. If it is determined 2150 thatthe user does respond before the end of the extended period of time Δtwith the information for the patient associated with the detectedsignal, then the process saves/stores 2160 the information in the userdevice and, when appropriate, transmits it to the central computer,which can be essentially immediately after the information is received,or at a preset later time, or manually after the user returns to thecentral computer. Regardless, of when or if the saved/stored informationis sent to the central computer, after it is saved/stored in the userdevice, the process returns to measuring 2120 the received RF signals.Alternatively, although not explicitly shown in the process, instead ofreturning to measuring 2120 after the information is saved/stored 2160,the process can end. The process described in FIG. 21 is designed toresolve the above-described inefficiency and context switching cyclingissues that can occur with the use of RF signals.

In the description of FIG. 21 provided above, for clarity ofunderstanding, the system was described in terms of detecting a beaconsignal from a single beacon with RF>=X. Of course, the system is morecomplex and can detect and simultaneously receive, process and act onmultiple beacon signals from multiple different beacons with RF>=X. Forexample, in one non-limiting example, after the initial detection of thefirst beacon signal with RF>=X, the observer T/R can and does continueto detect multiple beacon signals with RF>=X. These signals can comefrom the same beacon as the first beacon signal that was detected, aswell as multiple other beacons. Unfortunately, an observer can onlyenter information on one patient at a time into the observer T/R. If anyof the detected beacon signals with RF>=X are detected for the firstdetected beacon, the currently allocated time to receive input from theobserver can be immediately extended or a flag can be set or valuestored to extend the time for a response from the observer, if it isneeded. If not needed, the information can be cleared upon the receiptof the information from the observer.

Alternatively, and also as a non-limiting example, after the initialdetection of the first beacon signal with RF>=X, the observer T/Rdetects one or more beacon signals with RF>=X, but the one or moresignals this time come from different beacons. Because the observer isalready entering information on the one patient associated with thefirst detected beacon signal into the observer T/R. If any of thedetected beacon signals with RF>=X are detected for other beacons, oneor more flags can be set or values stored to indicate for which otherbeacons signals with RF>=X have been received and in what order. As soonas the system is free after the entry of the information for the firstsignal, the system can pull the next sequentially detected signal fromthe list, determine how much of the predetermined time it would haveleft to request and receive the information for that patient and, ifsufficient time remains, request and then wait to receive theinformation. While the other detected signals are waiting, they too canbe updated with additional time should additional signals of sufficientstrength be detected coming from that same beacon. Alternatively, ratherthan taking the next in line detected signal, it could be moreadvantageous to take the latest detected signal. This can be true forseveral reasons including, for example, but not limited to, the lastreceived signal is the most likely to have the longest time remaining toreceive the requested response and could be more likely that theobserver is still near the patient associated with the new beacon.

FIG. 22 is a combination block diagram of the electronic monitoringsystem using visual observation and RF signals from FIG. 1b and a flowchart illustrating the process followed by an observer to observe andmonitor one or more patients using an electronic patient monitoringsystem and decision making process, in accordance with an embodiment ofthe disclosed subject matter. In FIG. 22, the electronic patientmonitoring system and decision making process used can also be theprocess shown in FIG. 21. Regardless of which embodiment of theelectronic patient monitoring system and decision making process isimplemented, in addition to being implemented in the observer T/Rs 120′,it can be implemented in the central computer 130′, the PDAs 150′ and,if implemented, the fixed location T/Rs 122′. In FIG. 22, in addition tothe method of operation described above for FIG. 1b for the T/Rs 120,120′ and which is also applicable to FIG. 22, the patient ID Tag 110′can also send a signal directly to the one or more PDAs 150′ and thePDAs 150′ can display the patient status information displayed on theobserver T/Rs 120′. In turn, the PDAs 150′ can be used by an observer toenter the requested information and then transmit it to the centralcomputer 132′.

FIG. 23 is a generic user screen that can be implemented on a PDA orother handheld device, for example, which is similar to that shown inFIG. 8b , in accordance with an embodiment of the disclosed subjectmatter. In FIG. 23, an example of a visual display a user with the PDA150 or other handheld device can see, in general, and after a patientbeacon RF transmission is received by the PDA with the RF signal equalto or greater than the RF power level set as the threshold X to indicatea patient is in range. In other words, when the RF beacon signal>=X. Inthis example, panel ‘A’ indicates a patient whose received RF beaconpower transmission RF>=X, in which case, the display shows a ‘white’background indicating that the patient is in range and the observer canenter the necessary observation information into the system. Incontrast, patient ‘B’'s display is shown as a darker translucent overlay(shown in FIG. 23 as dark stippling). In this case, Patient ‘B’'s beacontransmission RF<X. In other words, patient ‘B’s beacon RF powertransmission level is less than the power threshold set.

As described herein, patient ‘A’s power level might be >=the threshold Xonly momentarily and might not even register on the display without theimplementation of an embodiment of the disclosed subject matterdescribed herein. For example, Patient ‘A’s display will display as‘in-range’ any patient for whom a signal was received with RF>=X, asshown in FIG. 23 for patient ‘A’, and the software will maintain the‘in-range’ display for specified period of time delta t (Δt). Forexample, Δt can be set to 0.9 sec to 10 sec. This mechanism creates apractical and clear distinction between an ‘in-range’ and an‘out-of-range’ patient for a period Δt, which is long enough for a userto see and act on the indication.

FIG. 24 is a flow chart illustrating the process from FIG. 3a that isfollowed by an observer using an electronic patient monitoring systemshowing where an electronic patient monitoring system and decisionmaking process can be implemented in the process, in accordance with anembodiment of the disclosed subject matter. As in FIG. 22, in FIG. 24,the electronic patient monitoring system and decision making processused can also be the process shown in FIG. 21. As seen in FIG. 24, theprocess outlined in FIG. 21 can be implemented in block 315 to monitorand control the detection, observation and recording of patient-specificinformation.

FIG. 25 is a flow chart illustrating the process from FIG. 3b that isfollowed by an observer using an electronic patient monitoring systemwith GPS and inter-patient distance monitoring showing where anelectronic patient monitoring system and decision making process can beimplemented in the process, in accordance with an embodiment of thedisclosed subject matter. As in FIGS. 22 and 24, in FIG. 25, theelectronic patient monitoring system and decision making process usedcan also be the process shown in FIG. 21. As seen in FIG. 25, theprocess outlined in FIG. 21 can be implemented in block 315′ to monitorand control the detection, observation and recording of patient-specificinformation.

In an embodiment of the disclosed subject matter, a system including acentral computer configured to store and execute program code to monitorand track observations of one or more patients assigned to one or moreobservers within a predetermined time interval; an observertransmitter/receiver (T/R) module configured to be attached to orcarried by each of the one or more observers, store and execute programcode to detect a proximity signal that exceeds a threshold level from anassigned patient, signal the observer of the detection, set a time toreceive information about the patient, receive the information about thepatient, and communicate the information about the patient to thecentral computer; a plurality of identification devices each configuredto be attached to one of the patients and to communicate at least aunique proximity signal of the identification device and can includepatient information to the observer T/R, each identification deviceincluding: a wristband comprising a section of a tamper resistantmaterial having opposite ends with a plurality of spaced holes on eachend; a beacon unit configured to emit a unique proximity signalassociated with that beacon; a clasp configured to secure and hold thebeacon unit and the wristband opposite ends via the plurality of spacedholes on each end together to form a closed loop, the clasp comprising atop portion adapted and configured to fit over and fixedly engage abottom portion with a plurality of spaced pins on a top of the bottomportion and a pair of non-retractable slides positioned in aperturesformed on opposite sides of the bottom portion and that fixedly engageopenings formed in inside surfaces of opposite longitudinal side wallsof the top portion; and at least one workstation configured tocommunicate with the central computer to receive information on theproximity of each patient to the observer T/R and observation checkwithin the predetermined time interval.

The above system embodiment can also include the observer T/R modulebeing further configured to perform a method including: activating atablet for each observer as an active Bluetooth or Bluetooth low-energyT/R and receiving in each tablet a listing of pre-assigned patients anda patient observation time schedule; detecting the beacon signal fromone of the pre-assigned patients, setting a time period in which toreceive information of the detected patient and receiving in the tabletpatient-specific information from the active Bluetooth or Bluetoothlow-energy transmitter associated with the observed patient; sending thereceived patient-specific information from the tablet to the centralcomputer including a time of observation of the one of the pre-assignedpatients; determining whether any observation times in the schedule havebeen missed for any of the pre-assigned patients and, if so, sendingalerts to at least a responsible observer and a nurses' workstation andlogging the missed observation for each determined missed observation;determining whether there are more patients to be observed in thelisting of pre-assigned patients and, if so, repeating steps b, c and d;and deactivating the tablet.

In an embodiment of the disclosed subject matter, a distributed systemwith multiple device processors communicatively connected to each otherand at least one of the processors configured perform acomputer-implemented method comprising: detecting a beacon signal in afirst processor when at least one radio frequency (RF) signal receivedfrom a beacon equals or exceeds a predefined signal strength threshold,the beacon signal being associated with and unique to a single entity;determining a proximity to the beacon in the first processor based onthe detected beacon signal strength; issuing an action request from thefirst processor based on the detected beacon signal being equal to orexceeding the predefined signal strength; waiting a predetermined timeperiod to receive a response to the action request, regardless ofsubsequently-received beacon signals continuing to exceed or not exceedthe predefined signal strength; receiving the response to the actionrequest; and recording the received response to the action request.

In an embodiment of the disclosed subject matter, an identificationdevice includes a wristband including: a section of a tamper resistantmaterial having opposite ends, the opposite ends of the wristband havinga plurality of openings formed therein adjacent to each of the oppositeends of the wristband and extending away from each end in along a commonaxis on the wristband; a clasp configured to secure and hold thewristband opposite ends together to form a closed loop, the claspincluding: a bottom portion including a plurality of pins extendedupwardly from and spaced longitudinally along a top of the bottomportion; a pair of non-retractable slides positioned in longitudinalgrooves along opposite sides of the bottom portion; and a top portionadapted and configured to fit over and fixedly engage the pins on thetop side of the bottom portion and the pair of non-retractable slides;and a beacon fixedly attached inside the clasp, the beacon configured totransmit a unique signal.

In an embodiment of the disclosed subject matter, an identificationdevice including: a wristband including a section of a tamper resistantmaterial having opposite ends, the opposite ends of the wristband havinga plurality of openings formed therein adjacent to each of the oppositeends of the wristband and extending away from each end in along a commonaxis on the wristband; a clasp configured to secure and hold thewristband opposite ends together to form a closed loop, the claspincluding: a bottom portion including a plurality of pins extendedupwardly from and spaced longitudinally along a top of the bottomportion; a pair of non-retractable slides positioned in longitudinalgrooves along opposite sides of the bottom portion; and a top portionadapted and configured to fit over and fixedly engage the pins on thetop side of the bottom portion and the pair of non-retractable slides;and a beacon fixedly attached inside the clasp, the beacon configured totransmit a unique signal.

In an embodiment of the disclosed subject matter, a system including: acentral computer including a processor configured to store and executeprogram code to monitor and track observations of patients received fromat least one observer; an observer transmitter/receiver (T/R) modulehaving a T/R processor, the module configured to be attached to orcarried by each of the at least one observers and to store and executeprogram code in the T/R processor to monitor and track observations ofpatients within an observer's predetermined proximity to patient withina determined time interval, the program code when executed by aprocessor in the T/R module performs a method including: detecting abeacon signal when at least one signal received from a beacon exceeds apredefined signal strength; determining a proximity to the beacon basedon the detected beacon signal strength; issuing an action request basedon the detected beacon signal exceeding the predefined signal strength;waiting a predetermined time period to receive a response to the actionrequest, regardless of subsequently-received beacon signals continuingto exceed the predefined signal strength; receiving the response to theaction request; and recording the received response to the actionrequest; an identification device configured to be attached to thepatient and to communicate at least the beacon signal of theidentification device and that can include patient information to theobserver T/R, the identification device including: a wristbandcomprising a section of a tamper resistant material having opposite endswith a plurality of spaced holes on each end; a clasp configured tosecure and hold the wristband opposite ends via the plurality of spacedholes on each end together to form a closed loop, the clasp comprising atop portion adapted and configured to fit over and fixedly engage abottom portion and a pair of non-retractable slides; and a beaconfixedly enclosed by the clasp; and at least one workstation having aworkstation processor, the at least one workstation configured tocommunicate with the central computer to receive information on theproximity of each patient to the observer T/R and observation checkwithin the predetermined time interval.

As will be appreciated from the foregoing description the presentdisclosed subject matter provides an electronic patient monitoringsystem that includes a not easily removable patient identification andmonitoring device affixed to a patient, an observer transmitter/receiverdevice to detect a beacon signal from the not easily removable patientidentification and monitoring device when the beacon signal exceeds orequals a signal threshold value and hold open a window on the observertransmitter/receiver device for the observer to enter information on thepatient, and a central computer system including, at least, a computerprocessor, communications components and system software to communicatewith the observer transmitter/receiver device at specified/predeterminedtime intervals to receive observer- and patient-specific information.

The disclosed subject matter having been described in certainembodiments, it will be apparent to those skilled in the art that manychanges and alterations can be made without departing from the spirit ofthe disclosed subject matter. Accordingly, Applicants intend to embraceall such alternatives, modifications, equivalents and variations inkeeping therewith.

What is claimed is:
 1. A system for monitoring a patient, the systemcomprising: a patient identification device, the patient identificationdevice comprising a beacon configured to emit a radio frequency (RF)beacon signal, the beacon signal being associated with and unique to asingle entity; an observer module configured to be operated by a user,the observer module comprising a receiver to detect the beacon signal; aprocessor in communication with the observer module, the processorincluding computer-program instructions, that, when executed by theprocessor, perform a computer-implemented method comprising: determininga beacon signal strength of the beacon signal received from the patientidentification device; determining when the beacon signal strength ofthe beacon signal received from the patient identification device equalsor exceeds a predefined signal strength threshold; determining that theobserver module is in-range to the beacon based on the determined beaconsignal strength; issuing an action request to the user when the beaconsignal strength that was detected is equal to or exceeds the predefinedsignal strength threshold; waiting a predetermined time period toreceive a response to the action request, regardless ofsubsequently-received beacon signals continuing to exceed or not exceedthe predefined signal strength threshold; receiving a response to theaction request from the user; and recording the response to the actionrequest that was received.
 2. The system of claim 1, wherein theprocessor issues the action request by issuing a visual or audiotrigger.
 3. The system of claim 1, wherein the processor determines thebeacon signal strength by comparing a strength of the beacon signalagainst the predefined signal strength threshold.
 4. The system of claim1, wherein the processor receives a response to the action request byreceiving a staff observation/interaction with the patient.
 5. Thesystem of claim 1, wherein the computer-implemented method furthercomprises setting the predefined signal strength threshold.
 6. Thesystem of claim 1, wherein the observer module is configured to beoperated on a mobile phone or PDA held by the user.
 7. The system ofclaim 1, wherein the patient identification device comprises a wristbandof a tamper resistant material configured to be secured to the patientso that the patient identification device cannot be removed by thepatient.
 8. The system of claim 1, wherein the processor is remote fromthe observer module.
 9. The system of claim 1, wherein the processor iswirelessly connected to the observer module.
 10. The system of claim 1,wherein the computer-implemented method further comprises presenting theaction request for an extended period of time that exceeds thepredetermined time period.
 11. The system of claim 1, wherein thecomputer-implemented method further comprises: determining whether theresponse to the action request that was received requires furtheraction; if the response to the action request that was received requiresone or more further actions, then initiating the one or more furtheractions, completing the one or more further actions, and recordingresults of the completed one or more further actions.
 12. The system ofclaim 1, wherein the computer-implemented method further comprises:determining whether a second beacon signal has been received thatexceeds the predefined signal strength threshold, then if a response tothe action request was received and the second beacon signal exceeds thepredefined signal strength threshold and the second beacon signal isassociated with the patient, resetting the predetermined time period torun from a time of receipt of the second beacon signal that exceeds thepredefined signal strength threshold; determining whether thepredetermined time period to receive a response to a second actionrequest has been exceeded; if the predetermined time period to receive aresponse to the second action request has been exceeded, then initiatingone or more predefined warning protocols; completing the one or morepredefined warning protocols; and recording results of the completed oneor more predefined warning protocols.
 13. A system for monitoring apatient, the system comprising: a patient identification device, thepatient identification device comprising a beacon configured to emit aradio frequency (RF) beacon signal, the beacon signal being associatedwith and unique to the patient, wherein the patient identificationdevice is configured to be secured to the patient so that the patientidentification device cannot be removed by the patient; an observermodule configured to be operated by a user, the observer modulecomprising a receiver to detect the beacon signal; and a processor inwireless communication with the observer module, the processor includingcomputer-program instructions, that, when executed by the processor,perform a computer-implemented method comprising: determining when asignal strength of the beacon signal detected by the receiver ofobservation module equals or exceeds a predefined signal strengththreshold; determining the user is in range of the patient based on thesignal strength of the beacon signal that was determined; issuing anaction request to the user based on the signal strength of the beaconsignal that was detected being equal to or exceeding the predefinedsignal strength threshold; waiting a predetermined time period toreceive a response to the action request, regardless ofsubsequently-received beacon signals continuing to exceed or not exceedthe predefined signal strength threshold; and recording the response tothe action request that was received.
 14. The system of claim 13,wherein the processor issues the action request by issuing a visual oraudio trigger.
 15. The system of claim 13, wherein the processormeasures a beacon signal strength to determine when the signal strengthof the beacon signal detected by the receiver of observation moduleequals or exceeds the predefined signal strength threshold.
 16. Thesystem of claim 13, wherein the observer module is configured to beoperated on a mobile phone or PDA held by the user.
 17. The system ofclaim 13, wherein the patient identification device comprises awristband of a tamper resistant material configured to be secured to thepatient so that the patient identification device cannot be removed bythe patient.
 18. The system of claim 13, wherein thecomputer-implemented method further comprises presenting the actionrequest for an extended period of time that exceeds the predeterminedtime period.
 19. The system of claim 13, wherein thecomputer-implemented method further comprises: determining whether theresponse to the action request that was received requires furtheraction; if the response to the action request that was received requiresone or more further actions, then initiating the one or more furtheractions, completing the one or more further actions, and recordingresults of the completed one or more further actions.
 20. A system formonitoring a patient, the system comprising: a wrist-worn patientidentification device, the wrist-worn patient identification devicecomprising a beacon configured to emit a radio frequency (RF) beaconsignal, the beacon signal being associated with and unique to thepatient, wherein the wrist-worn patient identification device comprisesa wristband of a tamper resistant material configured to be secured tothe patient so that the wrist-worn patient identification device cannotbe removed by the patient; a portable observer module configured to beoperated by a user, the portable observer module comprising a receiverto detect the beacon signal; and a processor in communication with theportable observer module, the processor including computer-programinstructions, that, when executed by the processor, perform acomputer-implemented method comprising: determining when a signalstrength of the beacon signal detected by the receiver of observationmodule equals or exceeds a predefined signal strength threshold;determining the user is in range of the patient based on the signalstrength of the beacon signal that was determined; issuing an actionrequest to the user based on the signal strength of the beacon signalthat was detected being equal to or exceeding the predefined signalstrength threshold; waiting a predetermined time period to receive aresponse to the action request, regardless of subsequently-receivedbeacon signals continuing to exceed or not exceed the predefined signalstrength threshold; and recording the response to the action requestthat was received.